No surprise here, but the Heartwire portion of the Lipid & Metabolic Heart.org site has an exclusive interview up -- with Dr. Kwan Leung Chan, the P.I. in ASTRONOMER. Do go read it all, but here is a bit:
. . . .The ASTRONOMER findings, as Chan noted, are in line with the SEAS and SALTIRE trials, two studies previously reported by heartwire. In SEAS, the combination of ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough Pharmaceuticals) failed to significantly alter clinical outcomes in roughly 1800 patients with aortic stenosis, with researchers showing the cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events. In SALTIRE, high-dose statin therapy with atorvastatin (Lipitor, Pfizer) failed to stop the progression of calcified aortic-valve stenosis.
To heartwire, Chan noted that those trials differed slightly from ASTRONOMER, most notably in that they included older patients, around 68 years of age. The SALTIRE study was also small, and patients with calcified valves were included. In contrast, the average patient age in ASTRONOMER was 58 years, and it was thought that an intervention in younger patients might be beneficial because the valve would not be as calcified as in older patients, although this proved not to be the case, he said. . . .
As an aisde, Merck CEO Dick Clark, in his talk at Goldman Sachs today, mentioned IMPROVE-IT -- and what he said, I don't think has been acknowledged officially by Merck, before: he said IF IMPROVE-IT reaches a half-way point during 2010, there will be a blinded look at the data. "IF" -- not "when" -- in 2010. Fascinating. I think it is at about 34:30 of this link. So -- it is a deeply-delayed potential future result (up or down) on the "outcomes" of the large (18,000 patient) IMPROVE-IT study -- and 0-for-3 on the small ones.
Ouch.
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